ISO-CARE KIT— 510(k) K781539

Substantially Equivalent

Nice-Pak Products, Inc.

FDA 510(k) clearance K781539 for ISO-CARE KIT, Substantially Equivalent on 1978-11-03. Applicant: Nice-Pak Products, Inc.. Device class: 1.

Clearance details

Applicant: Nice-Pak Products, Inc.
Product code: Code HMP
Device class: Class 1
Regulation: 21 CFR 878.4440
Advisory panel: General, Plastic Surgery
Date received: 1978-09-08
Decision date: 1978-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K874411 — DONALDSON NATURAL EYEPATCH 'PATIENT PAK'1988-01-27

More clearances from Nice-Pak Products, Inc.

K974768 — PDI STERILE LUBRICATING JELLY1998-01-16
K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT1984-03-27
K840343 — PDI PREPMASTER WET PACK VAGINAL-X214771984-03-27
K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE1984-03-26
K833549 — PDI SURGICAL SCRUB/BRUSH T150-701983-11-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.